FDA approves Novartis radioligand therapy Pluvicto® for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer

Core Viewpoint - The FDA has approved Novartis' Pluvicto® for earlier use in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), significantly expanding the eligible patient population and offering a new treatment option before chemotherapy [2][4][8]. Summary by Sections Approval and Indication Expansion - Pluvicto® is now approved for patients with PSMA-positive mCRPC who have been treated with an androgen receptor pathway inhibitor (ARPI) and are suitable for delaying chemotherapy, effectively tripling the number of eligible patients [2][3][7]. Clinical Trial Results - The Phase III PSMAfore trial demonstrated that Pluvicto reduced the risk of radiographic progression or death by 59% (HR=0.41; p<0.0001) compared to a change in ARPI, and it more than doubled the median radiographic progression-free survival (11.6 months vs. 5.6 months) [3][7]. - The overall survival analysis favored Pluvicto with a hazard ratio of 0.91, but was not statistically significant due to a high crossover rate from the control arm [4][6]. Safety Profile - Pluvicto exhibited a favorable safety profile, with most adverse events being Grade 1-2, including dry mouth (61%), fatigue (53%), nausea (32%), and constipation (22%) [5][6]. Market Impact and Patient Access - The expanded indication allows for earlier use of Pluvicto, addressing the need for effective therapies as nearly half of mCRPC patients do not live long enough to receive a second treatment [7][8]. - Novartis has established multiple RLT manufacturing facilities in the US to meet supply needs and ensure prompt delivery of Pluvicto to treatment sites [7][9]. Commitment to Education and Support - Novartis has launched the RLT Institute to educate healthcare providers on integrating radioligand therapy into clinical practice, ensuring safe administration and patient access [10][12]. - The company offers patient support services to assist with treatment initiation and insurance coverage [11][12].